Clinical trial · Interventional
A Nutrition & Exercise Prehabilitation Intervention on Inflammatory Biomarkers in AI Cancer Patients
A Nutrition and Exercise Prehabilitation Intervention on Inflammatory Biomarkers in American Indian Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to assess the feasibility of a prehab intervention among American Indian (AI) patients diagnosed with cancer and measure inflammatory biomarkers to evaluate the preliminary impact of the trial intervention. The central hypothesis is that this community-informed prehab intervention will demonstrate feasibility, patient acceptability, and modulation of host and tumor-microenvironment inflammatory biomarkers. Aim 1: Implement the prehab translational clinical trial for AI patients with cancer scheduled for treatment. Aim 2 Measure host and tumor-microenvironment (TME) biomarkers using paired serum and tissue samples to compare baseline and post-intervention levels of expression. Serum markers include CRP, IL-6, IL-10, TNFa, IGF-1, VEGF, complete blood count (CBC) with differential, comprehensive metabolic panel (CMP), and prealbumin. Tissue markers include Ki67, insulin receptor, TNFa, NFKB, NOS2, and cleaved caspase 3. Aim 3: (optional exploratory aim): Assess differential expression of inflammatory genes in the TME using tumor tissue samples to compare baseline and post-intervention levels of expression. This will be done with a panel that analyzes inflammatory genes only.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prehabilitation Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prehabilitation Intervention
- description
- This is a single-arm, pre-post, window of opportunity trial. The tailored prehab program will be implemented for AI cancer patients preparing for cancer treatment for a 3-week duration prior to their first treatment. The prehab intervention is designed to modify inflammatory biomarkers in paired pre/post-intervention blood and tissue samples. 30 individuals who are 18-80 years old with a diagnosis of cancer, scheduled at least 3 weeks out from cancer treatment who are receiving care at SCAHC will be recruited over the duration of the study. Blood samples will be collected before and after the prehab, and inflammatory biomarkers will be measured in the paired pre/post blood sample. Unstained slides from the diagnostic biopsy and resected tumor specimen will be requested, and inflammatory biomarkers will be measured in the paired pre/post tissue sample.
- interventionNames
- Behavioral: Prehabilitation Intervention
Primary outcomes (9)
- measure
- Patient enrollment and retention: proportion of patients who initiate the intervention, provide pre-intervention measurements and return for post-intervention measurements
- timeFrame
- Baseline and post-intervention (an average of 5 weeks)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18-80 years * Diagnosed with cancer of any kind * Scheduled at least 3 weeks out from first treatment * Receiving care at San Carlos Apache Healthcare Corporation (SCAHC) * Able to eat walnuts * Able to do moderate-intensity exercise Exclusion Criteria: * Digestive tract disease that would restrict diet modifications * Allergy to the foods intended for the nutrition intervention * Uncontrolled cardiac disease or other contraindications to moderate-intensity exercise
References
Publications (0)
Data not yet available